Clinical Pathway Adherence and Barriers to Coverage

Published Online: August 21, 2014

Poster Roundup

The health services research poster session held in the afternoon on June 1, 2014, the penultimate day of the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, presented varying perspectives on issues that determine patient care decisions. This is an important discussion, especially in light of the recent report by The Wall Street Journal on WellPoint’s effort to promote oncologist adherence to standardized treatment guidelines.1 WellPoint has begun its initiative to offer oncologists a $350 per month payment for every patient who is on 1 of the insurer’s recommended regimens.

With the cost of cancer care in the United States projected to exceed $173 billion by 2020, clinical pathways can help curb spending by reducing unnecessary and costly treatment variations while improving patient outcomes. Cardinal Health Specialty Solutions evaluated cost savings of a payer-sponsored pathway program for patients

with cancer receiving their first chemotherapy intervention. A large payer for the Mid-Atlantic region of the United States collaborated with its community oncology provider network to create a 3-year pathway program, managed by Cardinal Health, for chemo-naïve patients with breast cancer (BC), colorectal cancer (CRC), and lung cancer. All drug costs were standardized to average sales price effective in the last quarter of the program year, and participating physicians received financial incentives. The study included a total of 453 patients, and savings relative to projected cost per patient, per year for pathway cohorts were $21,106 for CRC and $2964 for lung cancer. For BC, the cost increased by $9271. Overall mean cost per patient, adjusted for trastuzumab use (29% study vs 21% control), decreased 5% ($1698 per patient per year) for an aggregate savings of $750,436. The study concluded that voluntary pathway participation can lower drug cost of common malignancies

even in first-line treatment. The approach of limiting pathway inclusion to chemotherapy-naïve patients will provide the greatest clarity of pathway impact throughout the duration of illness.

2. Barriers to insurance coverage of next-generation tumor sequencing by US payers3

Next-generation tumor sequencing (NGTS) panels are increasingly being used in the clinical setting, but are not formally covered by payers in the United States. Lack of consistent coverage policy may impact access and adoption. The current study aimed to identify considerations used by payers for NGTS coverage decisions. Semistructured interviews with senior executives of 7 large national and 3 regional plans in the United States, covering more than 125 million members, found that most payers (80%) believe NGTS has a potential to transform cancer care, but all (100%) report barriers to coverage. The current policy stems from the lack of exhaustive

data validation. (1) 70% of payers wanted evidence for 1 target and 1 cancer type at a time, rather than a bundle. (2) 80% of payers may predicate coverage policy for NGTS based on the validity of included targets, and also on outcomes from therapies informed by NGTS, with 30% requiring phase 3 evidence for each new marker/drug indication. (3) 70% of payers wanted additional clarification and increased evidence that NGTS is “medically necessary” and not “experimental or investigational.” Therefore, payers may not cover panels that include novel targets. (4) Payers cite challenges in assessing accuracy and value of bioinformatics required to implement NGTS. Nearly three-fourths of payers did not believe that bioinformatics should be reimbursed. Based on this study, the authors concluded that NGTS does not fit the current payer coverage and evidence framework and thus faces potential barriers to access. The entry of this rapidly evolving technology into clinical practice requires ongoing dialogue among payers, providers, and policy makers to develop an innovative road map to coverage and reimbursement.

The H. Lee Moffitt Cancer Center and Research Institute (MCC) in Tampa, Florida, has developed and implemented clinical pathways across disease-focused programs.

This collaborative study between MCC and QURE Healthcare performed a series of measurements of adherence to evidence-based clinical pathways, which included subsequent educational feedback on performance. Using Clinical Performance and Value (CPV) vignettes, a validated in-silico simulation measurement tool, they evaluated breast cancer (BC) clinical pathway adherence every 4 months. Eighteen providers completed 2 BC cases each, at months 1, 5, and 9. Clinicians received

confidential individualized feedback for each case, with quantitative feedback benchmarked to their peers and qualitative individual feedback with suggestions on how they could improve pathway adherence. Baseline measurement revealed wide variance levels of adherence to pathways across the clinician cohort. With serial measurement and feedback, mean computer percentage value scores increased significantly from 55.4% at round 1 to 68.8% at round 3 (P <.01). Particularly, chemotherapy pathway compliance increased from 40% to 65%, appropriate diagnostic work from 31% to 93%, and surgery pathway compliance from 69% to 86%. The authors concluded that adherence to clinical pathways can be improved with a serial measurement and feedback tool. Future studies are planned to link these changes to utilization and costs. Consistent feedback at the individual and group level engages and aligns providers around pathways and common practice standards. EBO